Return of the Medi

17. June 2010

For all of you having trouble swallowing your pills and fearing the syringe like the devil fears holy water – salvation is upon the way. We could create holes in our skin with a therapeutic laser sword and – well – “shoot“ drugs straight and safely into our body.

If you think that Liechtenstein only knows how to do banks you’re on the wrong track – for Lichtenstein is the place where the company Pantec Biosolutions is located. This company is mustering to revolutionize the application of drugs by using state-of-the-art laser technology. Instead of making all those expensively manufactured, therapeutically effective substances suffer from the tight and sour stomach passage or injecting them ‘with the gloves off’, i. e. blood vessels, into subcutaneous fat tissue or the muscle, Pantec wants to enter drugs gently through the skin by using laser. They want to succeed with a device which currently looks like a massage device for use at home.

Boring with telescope sight

The principle is quite obvious: To battle out the fight between conventional transdermal therapeutic systems and the tough epidermis of human skin and to make it a bit more targeted, the patient gets a device put on his skin called P.L.E.A.S.E., manufactured by Pantec. The semantics of P.L.E.A.S.E. might not be really convincing, the abbreviation stands for “Painless Laser Epidermal System”. With the push of a button P.L.E.A.S.E. gets started and perforates the skin with laser beams – oops… Meaning: Creates micropores which allow even drugs with large molecules to enter the body fully ad lib. The charm of the system is supposed to lie in the fact that number and depth of the pores are variable. Thus the number of pores can be adjusted to individual requirements i. e. the amount of the substance to be applied. It can produce up to 5000 pores per array with a diameter of round and about 200 micrometers. Also the depth of the pores is variable which is important because P.L.E.A.S.E. is supposed to be designed to perforate only callus and epidermis but not the dermis which is full of vessels and nerves. In increments of five to ten micrometers, the laser bores ablated through the upper skin layers and stops as soon as the environment “feels” like dermis. If you want to take a closer look you are welcome to watch this video.

Study: Something grand is going through these holes

At present the manufacturer has submitted first study data, i. e. from a clinical phase I-study with healthy volunteers. Target of the study was to evaluate safety and compatibility of a combination of laser treatment and band-aid containing FSH. FSH, the follicle-stimulating hormone, was selected because it provides a potential application scenario for the P.L.E.A.S.E. laser. FSH is used – among other things – during in-vitro-fertilization to accelerate the growth of follicles. It is a large and relatively sensitive hormone which up to now was injected subcutaneous or intramuscular. Facing the often repeated IVF cycles, it for sure isn’t pure fun.

During this study, the skin of men was perforated with the laser technology first. Then FSH-band-aids were put on the perforate area. The result: The FSH-serum level showed that the 32 KDa-protein was actually absorbed through the skin. The admission was done with a reproducible pharmacokinetic which shows very little inter-individual variations. “This study shows for the first time that P.L.E.A.S.E. enables to transfer large proteins like FSH in therapeutic amounts from stable band-aids”, emphasizes Christof Boehler, CEO of Pantec. “This study is an important mile stone for us on the road to commercialization.”

Before, a study with twelve volunteers examined whether the perforation of the skin was half way tolerable for the test persons – and it was! 20 percent stated that in this case – with 150 created micropores – they did not have any troubles with it. An additional 70 percent reported minor inconveniences. Objectively we are talking about redness of the skin that vanishes after either a few hours or a few days. The histological examination of the pores area did not give any indications of heat damage. Looks like a start has been made.